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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F
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BARD ACCESS SYSTEMS POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F Back to Search Results
Model Number 1808051
Medical Device Problem Code Migration or Expulsion of Device (1395)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number was provided, therefore a lot history review could be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.The definitive root cause is unknown.The device is labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 1808051 implantable port allegedly experienced migration.This information was received from one source.This malfunction involved a patient with no consequences.Age, weight, and gender of the patient was not provided.
 
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Brand Name
POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F
Common Device Name
IMPLANTABLE PORT
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key10289330
Report Number3006260740-2020-02519
Device Sequence Number13656146
Product Code LJT
UDI-Device Identifier00801741027017
UDI-Public(01)00801741027017
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number1808051
Device Catalogue Number1808051
Device Lot NumberREEN5000
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/30/2020
Initial Report FDA Received Date07/17/2020
Patient Sequence Number1
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